Diamyd Medical, a Swedish diabetes company focusing on the development of pharmaceuticals for the treatment of autoimmune diabetes and its complications, reports today that the United States Food and Drug Administration has approved the experimental use of Diamyd® vaccine in children as young as 3 years of age in the TrialNet GAD study, enrolling 126 new onset type 1 diabetes patients in North America.
The TrialNet GAD study, conducted by an international network of leading pediatric and adult endocrinologists and immunologists, has previously enrolled new onset type 1 diabetes patients from 16 to 45 years of age, but is now allowed by the FDA to enroll and administer the Diamyd® vaccine to children as young as 3 years of age.
The company said the approval to enroll small children in the TrialNet study is based on an FDA review of safety data from our ongoing Phase III trials, and further supports that the Diamyd® vaccine’s safety profile is strong.
